Registration Dossier

Administrative data

Description of key information

DCP is of moderate acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
860 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
9 240 mg/m³
Quality of whole database:
Key Studies are prior to GLP but are of sufficient quality for interpretation.

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50

Additional information

DCP has a low order of toxicity to rats and guines pigs by the oral route (LD50 1940-2200mg/kg), but is of moderate toxicity to the mouse (LD50 860-960mg/kg). Acute inhalation data on DCP demonstrated a 4-h LC50 value of 2000 ppm in rats (the preferred species based on Globally System on Classification and Labeling of Chemicals, 3rd Revised Edition United Nations (2009)), which is equivalent to 9.24 mg/L. A 6 -h LC50 value of 500 ppm in mouse (not the preferred species) was also described, which can be translated to a 4 -h equivalent of 2.64 mg/L.

Justification for selection of acute toxicity – inhalation endpoint
Acute inhalation data on DCP demonstrated a 4-h LC50 value of 2000 ppm in rats (the preferred species based on Globally System on Classification and Labeling of Chemicals, 3rd Revised Edition United Nations (2009)), which is equivalent to 9.24 mg/L.

Justification for classification or non-classification

Classification for acute toxicity is based either on the preferred species or on the most sensitive species for which data are available.  For the oral route, mouse is chosen (although not typically the preferred species) and DCP is classified as harmful (DSD: Xn; R22: Harmful if swallowed; GHS: Acute Oral Toxicity Cat 4, H302: Harmful if swallowed).

Acute inhalation data on DCP demonstrated a 4-h LC50 value of 2000 ppm in rats (the preferred species based on Globally System on Classification and Labeling of Chemicals, 3rd Revised Edition United Nations (2009)), which is equivalent to 9.24 mg/L. A 6-h LC50 value of 500 ppm in mouse (not the preferred species) was also described, which can be translated to a 4-h equivalent of 2.64 mg/L.  Although the standard conversion of the existing DSD Xn; R20 into GHS classification is Cat 4 H332, both of these inhalation LC50 values meet the criteria for Cat 3, therefore Acute Inhalation Toxicity Cat 3, H331: Toxic if inhaled, is applied instead via self-classification.  Overall classification of DCP for acute toxicity is as follows:

DSD: Xn; R20/22: Harmful if swallowed, according to Annex I of Directive 67/548/EEC for health hazards.

GHS: Acute Oral Toxicity Cat 4, H332: Harmful if swallowed; Acute Inhalation Toxicity Cat 3, H331, Toxic if inhaled, according to self-classification.